Tissue-engineered oral mucosa cells for treatment of urethral strictures

Información del proyecto

TETUS

Identificador del acuerdo de subvención: 823126

DOI

10.3030/823126

Proyecto cerrado

Fecha de la firma de la CE 12 Julio 2018

Fecha de inicio 1 Agosto 2018

Fecha de finalización 31 Julio 2021

Financiado con arreglo a

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coste total

€ 2 630 270,00

Aportación de la UE

€ 1 841 189,00

Coordinado por

MUKOCELL GMBH
Germany

Periodic Reporting for period 3 - TETUS (Tissue-engineered oral mucosa cells for treatment of urethral strictures)

Período documentado: 2020-08-01 hasta 2021-07-31

Resumen del contexto y de los objetivos generales del proyecto

Urethral stricture is a relatively common disease and an unmet medical need with an associated prevalence of about 200-600 cases per 100,000 males in Europe. Recurrent urethral stricture is a common secondary disease and affects 30% to 90% of suffering patient population depending on the treatment performed for the first time (the chances of recurrence increase by time). The conventional methods are completely incapable of alleviating Recurrent urethral stricture .
MukoCell® is the first and only tissue-engineered Advanced Therapeutic Medicinal Product (ATMP) for treatment of urethral strictures in the world. MukoCell®-Therapy at its current stage decreases the number of necessary surgeries to one (no need to obtain native tissue from the mouth in case of Urethroplasty) and decreases the chance of recurrence (associated with Urethrotomy).
The overall objective of the project is to valid MukoCell® in clinical environment and demonstrate its superiority and benefits compared to the Standard of Care and to make it ready for launch in the European markets by performing a market replication.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

In the first year of the project the clinical partners were aquired and signed into the cooperation agreement. The positive opinion of the ethical committee was obtained and a S1 Laboratory was set up to fulfill the requirements of EMA for product safety and quality as the study medication. In parallel, the project was communicated to the public audience and the professionals to make them aware of the benefits of the MukoCell. To make the product available to the market reimbursement was negotiated with public and private insurance companies and obtained the support of two private insurance companies to reimburse treatment with MukoCell.
The exiting quality attributes of the product was submitted formally to PEI and additional required quality attributes were discussed in a meeting and the periodic quality report was submitted. In a product safety report the side effects and complications in 200 patients was submitted to PEI. Due to the absence of major side effects, the product was considered to be correspondingly safe. The transfer of the production line to the new subcontractor, CODON AG, is in process.To validate the product, 14 clinics from three different countries are recruited into a randomised pivotal clinical study. Positive opinion from the Ethics Committee of the Principal Investigator in Germany is obtained, and the application is submitted to the responsible Italian and Swiss agencies.

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

It is expected that by the end of this project, MukoCell is ready to reach a Technologly Readiness Level of 7 and to be prepared for clinical product validation and qualification.

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